MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT ANTI-HBS REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 07C18-29

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information is included.Additional patient details are not available.

Event Description

The customer reported a (b)(6) anti-hbs results for one patient with monoclonal gammopathy.The customer provided: on (b)(6) 2020 initial = 758 miu/ml; on (b)(6) 2020 initial = 7 miu/ml; on (b)(6) 2020 initial = 285 miu/ml [(interpretation range: < 10.00 miu/l = (b)(6); >= 10.00 miu/l = (b)(6)].All other (b)(6) markers were stated to be (b)(4).There was no reported impact to patient management.There was no reported impact to patient management.

Manufacturer Narrative

The complaint investigation included a search for similar complaints, and the review of the complaint text, trending data, labelling, device history records and field data.Return testing was not completed as returns were not available.Review of trending reports determined no trend for the issue and the product.Device history record review of lot 13536fn00 did not show any non-conformances or deviations.Labelling and literature were reviewed which adequately addresses the issue under review.World wide field data associated with lot 13536fn00 was reviewed.The median patient result for the lot was within 1sd of the established baseline, indicating this reagent lot is performing acceptably on market and is comparable with other lots in the field.Based on the investigation, no systemic issue or deficiency of the architect anti-hbs assay, lot number 13536fn00 was identified.D3 date of event was changed from (b)(6) 2020 to (b)(6) 2020 to reflect the date the false negative result was generated.

Event Description

The customer reported a false reactive anti-hbs results for one patient with monoclonal gammopathy.The customer provided: on (b)(6) 2020 initial = 758 miu/ml; on (b)(6) 2020 initial = 7 miu/ml; on (b)(6) 2020 initial = 285 miu/ml (interpretation range: < 10.00 miu/l = nonreactive; >= 10.00 miu/l = reactive).All other hbv markers were stated to be non-reactive.There was no reported impact to patient management.There was no reported impact to patient management.

Manufacturer Narrative

Section b3 date of event was incorrectly updated in follow up 01.The date was corrected to 29sep2020 to reflect the date the first false positive result was generated.Section b5 a note was added to correct the date the negative result (7miu/l) was generated.The date was initially incorrectly documented as (b)(6) 2020 and was corrected to (b)(6) 2019.No further updates are necessary.

Event Description

The incorrect date of (b)(6) 2020 was documented in the initial report for the negative result of 7 miu/l.The correct test date should be (b)(6) 2019.

• Brand Name: ARCHITECT ANTI-HBS REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 10999694
• MDR Text Key: 242419258
• Report Number: 3008344661-2020-00137
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• PMA/PMN Number: P050051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2021
• Device Catalogue Number: 07C18-29
• Device Lot Number: 13536FN00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR ANALYZER G-, 03M74-95, ISR01231; ARC I2000SR ANALYZER G-, 03M74-95, ISR01231; ARC I2000SR ANALYZER G-, 03M74-95, ISR01231